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    Summary
    EudraCT Number:2016-000936-17
    Sponsor's Protocol Code Number:GWEP1560
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-07-26
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2016-000936-17
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled Single-Ascending Dose Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of GWP42003-P in Conjunction with Hypothermia in Neonates with Moderate or Severe Hypoxic Ischemic Encephalopathy
    Ensayo aleatorizado de dosis única en pauta ascendente, controlado con placebo y con doble enmascaramiento para evaluar la seguridad, la tolerabilidad y la farmacocinética del GWP42003-P junto con la hipotermia terapéutica en recién nacidos con encefalopatía hipóxico-isquémica moderada o grave
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomized trial to evaluate the safety, tolerability, and pharmacokinetics of GWP42003-P in conjunction with therapeutic hypothermia in neonates with moderate or severe birth asphyxia
    Un ensayo aleatorizado para evaluar la seguridad, la tolerabilidad y la farmacocinética de GWP42003-P junto con hiptermia terapéutica en neonatos con asfixia de moderada a grave en el momento de nacer
    A.4.1Sponsor's protocol code numberGWEP1560
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGW Research Ltd
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGW Research Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGW Research Ltd
    B.5.2Functional name of contact pointGW Research Ltd Switchboard
    B.5.3 Address:
    B.5.3.1Street AddressSovereign House, Vision Park, Chivers Way
    B.5.3.2Town/ cityHiston, Cambridge
    B.5.3.3Post codeCB24 9BZ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+34659356330
    B.5.5Fax number+441223235667
    B.5.6E-mailinfo@gwpharm.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/15/1520
    D.3 Description of the IMP
    D.3.1Product nameCannabidiol (CBD)
    D.3.2Product code GWP42003-P
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCannabidiol
    D.3.9.1CAS number 13956-29-1
    D.3.9.2Current sponsor codeGWP42003-P
    D.3.9.3Other descriptive nameCANNABIDIOL
    D.3.9.4EV Substance CodeSUB26600
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product Yes
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product Yes
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Neonatal Hypoxic-Ischemic Encephalopathy
    encefalopatía hipóxico-isquémica moderada o grave
    E.1.1.1Medical condition in easily understood language
    Brain injury caused by a lack of oxygen-rich blood in a newborn's brain
    Lesión cerebral causada por la falta de oxigenación en el cerebro de los recien nacidos
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10070512
    E.1.2Term Hypoxic-ischemic encephalopathy
    E.1.2System Organ Class 100000004852
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10050081
    E.1.2Term Neonatal hypoxia
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the safety and tolerability of a single-ascending intravenous (IV) dose of GWP42003-P compared with placebo in neonates (minimum of 36 weeks plus 0 days gestational age) who are undergoing whole-body hypothermia (standard of care) for the treatment of NHIE
    Evaluar la seguridad y la tolerabilidad de una dosis única en pauta ascendente y por vía intravenosa (i.v.) del GWP42003-P frente a placebo en recién nacidos (como mínimo, 36 semanas + 0 días de edad gestacional) expuestos a hipotermia terapéutica de cuerpo completo como tratamiento de referencia de la EHIN.
    E.2.2Secondary objectives of the trial
    To determine the pharmacokinetics (PK) of cannabidiol (CBD) following a single IV dose of GWP42003-P
    The exploratory objectives of this trial are
    To assess the efficacy of a single IV dose of GWP42003-P compared with placebo in neonates who are undergoing whole-body hypothermia for the treatment of NHIE with respect to the following:
    Degree of brain injury/recovery
    Seizure burden
    Neurodevelopmental impairment
    Determinar la farmacocinética (FC) del canabidiol (CBD) tras una dosis única del GWP42003-P por vía i.v.
    Los objetivos exploratorios son:
    Evaluar la eficacia de una dosis única del GWP42003-P por vía i.v.
    frente a placebo en recién nacidos expuestos a hipotermia
    terapéutica de cuerpo completo como tratamiento de la EHIN por lo
    que respecta a los siguientes factores:
    • Nivel de daño cerebral/rehabilitación.
    • Carga de crisis convulsivas.
    • Alteración del desarrollo neurológico.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patient is male or female and > or = 36 weeks of gestational age
    - Patient is receiving active or passive whole-body cooling/hypothermia since <6 hours from birth
    - Patient has perinatal depression based on at least 1 of the following:
    • Apgar score < or = 5 at 10 minutes, or;
    • Need for resuscitation at 10 minutes (i.e., endotracheal or mask ventilation, or chest compressions), or;
    • pH < 7.00 in umbilical cord, arterial, or capillary blood < 60 minutes of age, or;
    • Base deficit > or = 16 mmol/L in umbilical cord or any blood sample (arterial,venous, or capillary) < 60 minutes of age.
    - Patient has moderate to severe encephalopathy consisting of altered state of consciousness (lethargy, stupor, or coma) AND at least 1 of the following:
    • Hypotoni
    • Abnormal reflexes, including oculomotor or pupillary abnormalities
    • An absent or weak suck
    • Clinical seizures
    -Patient has > or = 30 minutes’ duration of abnormal background activity on cEEG prior to IMP administration, based on the presence of 1 of the following:
    • Suppressed activity
    • Moderately abnormal activity
    • Seizures of 30 seconds’ duration or more
    - Patient’s parent(s)/legal representative (if appropriate according to local laws) is/are willing and able to give informed consent for participation in the trial
    - Patient’s parent(s)/legal representative (if appropriate according to local laws) is/are willing and able (in the PI’s opinion) to comply with all trial requirements
    - Patient’s parent(s)/legal representative is/are willing to allow the responsible authorities to be notified of participation in the trial, if mandated by local law
    - Patient’s parent(s)/legal representative (if appropriate according to local laws) is/are willing to allow his or her primary care practitioner (if they have one) and consultant (if they have one) to be notified of participation in the trial if the primary care practitioner/consultant is different from the PI
    - El paciente debe ser hombre o mujer y tener > o = 36 semanas de edad gestacional.
    - Exposición a hipotermia terapéutica o enfriamiento activo o pasivo de cuerpo completo < 6 horas después del
    nacimiento.
    - Hiporreactividad perinatal de acuerdo con al menos uno de los siguientes factores:
    o Índice de Apgar < o = 5 tras 10 minutos.
    o Necesidad de reanimación tras 10 minutos (es decir, ventilación mecánica mediante mascarilla, intubación endotraqueal o masaje cardíaco).
    o pH < 7,00 en la sangre de las arterias, los capilares o el cordón umbilical < 60 minutos después del nacimiento.
    o Deficiencia de base > o = 16 mmol/l en el cordón umbilical o cualquier muestra de sangre (arterial, venosa o capilar) < 60 minutos después del nacimiento.
    - Encefalopatía moderada o grave que implique una alteración del estado de consciencia (letargo, estupor o coma) Y al menos uno de los siguientes factores:
    o Hipotonía.
    o Reflejos anómalos (anomalías oculomotoras o pupilares incluidas).
    o Succión nula o deficiente.
    o Crisis convulsivas.
    - La duración de la actividad de fondo anómala en la EEGc anterior a la administración del fármaco experimental (FE) del paciente es > o = 30 minutos vista la presencia de una de las siguientes variables:
    o Ausencia de actividad.
    o Actividad medianamente anómala.
    o Crisis convulsivas de 30 segundos o más.
    - Los padres o representantes legales del paciente (si procede de acuerdo con la legislación local) están dispuestos y capacitados para autorizar la participación del paciente en el ensayo.
    - Los padres o representantes legales del paciente (si procede de acuerdo con la legislación local) están dispuestos y capacitados (en opinión del IP) para ajustarse a todos los requisitos del ensayo.
    - Los padres o representantes legales del paciente están dispuestos a permitir que se notifique a las autoridades competentes la participación del paciente en el ensayo, si así lo estipula la legislación local.
    - Los padres o representantes legales del paciente (si procede de acuerdo con la legislación local) están dispuestos a permitir que se notifique al médico de cabecera/especialista del paciente (si los hay) la participación del paciente en el ensayo, si ninguno de estos es el IP.
    E.4Principal exclusion criteria
    - Patient’s mother used recreational or medicinal cannabis or synthetic cannabinoid-based medications (including Sativex) within 4 weeks of birth of the patient
    - IMP cannot be administered within 12 hours of birth and after whole-body hypothermia has been initiated
    - Patient’s birth weight < 1800 g (e.g., intrauterine growth restriction)
    - Patient has severely abnormal background activity on continuous electroencephalography (cEEG) classified by continuous electrographic seizures suggestive of status epilepticus
    - Patient has potential hypersensitivity to cannabinoids or any of the excipients of the IMPs based on family history
    - Patient has a living twin (or higher order multiple) who is also being cooled
    - Patient’s head circumference is < 30 cm
    - Redirection of the patient’s care is being considered due to moribund condition
    - Patient’s parents have diminished capacity and autonomy
    - Patient has a serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 × upper limit of normal (ULN)
    - Patient has a genetic or congenital condition that affects neurodevelopment or requires multiple surgeries (e.g., congenital viral infection, hydrops, complex congenital heart disease, severe dysmorphic features, etc.)
    - Patient has any other significant disease or disorder that, in the opinion of the PI, may put the patient at risk because of participation in the trial, may
    influence the result of the trial, or may affect the patient’s ability to take part in the trial
    - Any abnormalities identified following a physical examination of the patient that, in the opinion of the PI, would jeopardize the safety of the patient orinterfere with trial conduct if they took part in the trial
    - Patient is participating in another interventional trial (note: this does not include observational studies)
    - La madre consumió marihuana medicinal o recreativa o medicamentos canabinoides sintéticos (incluido Sativex) a lo largo de las cuatro semanas previas al nacimiento del paciente.
    - No es posible administrar el FE en un plazo de 12 horas tras el nacimiento y tras iniciar la hipotermia terapéutica de cuerpo completo.
    - El peso del recién nacido es < 1800 g (p. ej., por restricción del crecimiento intrauterino).
    - El paciente presenta anomalías graves de la actividad en la EEGc por las crisis convulsivas electrográficas continuas,
    que apuntan a epilepsia.
    - El paciente podría ser alérgico a los canabinoides o a cualquiera de los excipientes del FE según los
    antecedentes familiares.
    - El paciente tiene un gemelo vivo (o varios) y también está expuesto a hipotermia terapéutica.
    - El perímetro cefálico del paciente es < 30 cm.
    - Se está contemplando la posibilidad de modificar la dirección de la asistencia sanitaria debido al estado moribundo del paciente.
    - Los padres presentan una capacidad intelectual y autonomía reducidas.
    - El valor de la alanina transaminasa (ALT) o la aspartato transaminasa (AST) en suero del paciente es > 3 veces el límite superior de la normalidad.
    - El paciente tiene una afección congénita o genética que afecta a su desarrollo neuronal o requiere de varias intervenciones quirúrgicas (p. ej., infección vírica congénita, eritroblastosis fetal, cardiopatía congénita compleja, rasgos
    dismórficos importantes, etc.).
    - El paciente sufre otras afecciones o trastornos graves que, en opinión del IP, pueden representar un riesgo si participa en
    el ensayo, pueden afectar a los resultados del ensayo o pueden repercutir en su capacidad para participar en el
    ensayo.
    - Cualquier anomalía identificada como parte de la exploración física del paciente que, en opinión del IP, pueda poner en riesgo la seguridad del paciente o interferir en la ejecución del ensayo si este participa.
    - El paciente está participando en otro ensayo clínico de intervención (nota: no se incluyen los ensayos clínicos observacionales).
    E.5 End points
    E.5.1Primary end point(s)
    The safety and tolerability profile of a single IV dose of GWP42003-P, compared with placebo, will be assessed through monitoring of the following:
    • Frequency, type, and severity of adverse events (AEs) up to 30 days of life
    • Mortality rate up to 30 days of life
    • Clinically significant changes in the following up to discharge from the neonatal intensive care unit (NICU):
    o Laboratory parameters
    o Cardiorespiratory monitoring
    o Vital signs
    Se evaluará la seguridad y la tolerabilidad de una dosis única del GWP42003-P de administración por vía i.v. frente a placebo de acuerdo con los siguientes factores:
    • Frecuencia, tipo e intensidad de los AA hasta alcanzar los 30 días de vida.
    • Tasa de mortalidad hasta alcanzar los 30 días de vida.
    • Cambios clínicamente significativos durante el periodo de seguimiento y hasta el alta de la UCI neonatal:
    o Parámetros analíticos.
    o Exploración cardiorrespiratoria.
    o Constantes vitales.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Physical and Neurological Exam: Visits 1, 2, 3, 4, 5 and 7.
    Vital Signs: Hourly from birth to 24 hours postnatal and every 4 hours until 120 hours postnatal
    Respiratory Support: Every 8 hours from birth until 120 hours postnatal.
    Safety Laboratory Sampling: Prior to IMP administration, at 36 hours (+/- 12 hours) of life and 72 hours (+/- 12 hours) of life.
    Clinical Laboratory Sampling: Per routine care throughout hospitalization.
    Exploraciones físicas y neurológicas: Visitas 1, 2, 3, 4, 6 y 7
    Constantes vitales: cada hora desde el nacimiento hasta las 24 horas poteriores y cada 4 horas hasta las 120 horas posteriores al nacimiento
    Soporte respiratorio: cada 8 horas desde el nacimient has 120 horas tras el nacimiento
    Muestras de laboratorio de seguridad: antes de la administración del medicamento en investigación, a las 36 horas (+/- 12 horas) de vida y a las 72 horas (+/- 12 horas) de vida
    Muestras de laboratorio clíncas: según la práctica clínica habitual en la hospitalización
    E.5.2Secondary end point(s)
    The plasma PK of CBD will be investigated. Plasma PK parameters will be determined using a population-based approach with sparse sampling.
    Se investigará la farmacocinética del CBD. Los parámetros farmacocinéticos se determinarán usando un enfoque poblacional con muestreo disperso
    E.5.2.1Timepoint(s) of evaluation of this end point
    PK Samples completed 2 minutes prior to completion of the infusion and at 1, 2, 4 and 8 hours after the end of infusion.
    Las muestras para farmacocinética se recogerán cada 2 minutos antes de completar la infusión y a 1 hora, 2, 4 y 8 horas tras finalizar la infusión
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tolerabilidad
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Safety, Tolerability and Pharmacokinetics
    Seguridad, tolerabilidad y farmacocinética
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 32
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F.1.1.2.1Number of subjects for this age range: 16
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.3.1Number of subjects for this age range: 16
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Paediatric (Newborn) Population
    Población pediátrica (neonatos)
    F.4 Planned number of subjects to be included
    F.4.1In the member state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 32
    F.4.2.2In the whole clinical trial 32
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    This is a single dose IMP administration, no further treatment will be given. Routine standard of care will be continued after the subject has ended participation in the trial.
    El ensayo contempla una única administración del producto en investigación, no habrá más tratamiento. Tras la finalización del ensayo se seguirá la práctica clínica habitual.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-11-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-06-22
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